BibTex format
@unpublished{Gibani:2020:10.1101/2020.08.13.20174193,
author = {Gibani, M and Toumazou, C and Sohbati, M and Sahoo, R and Karvela, M and Hon, T-K and De, Mateo S and Burdett, A and Leung, F and Barnett, J and Orbeladze, A and Luan, S and Pournias, S and Sun, J and Flower, B and Bedzo-Nutakor, J and Amran, M and Quinlan, R and Skolimowska, K and Klaber, R and Davies, G and Muir, D and Randell, P and Crook, D and Taylor, G and Barclay, W and Mughal, N and Moore, L and Jeffery, K and Cooke, G},
doi = {10.1101/2020.08.13.20174193},
publisher = {Cold Spring Harbor Laboratory},
title = {CovidNudge: diagnostic accuracy of a novel lab-free point-of-care diagnostic for SARS-CoV-2},
url = {http://dx.doi.org/10.1101/2020.08.13.20174193},
year = {2020}
}
RIS format (EndNote, RefMan)
TY - UNPB
AB - Background Access to rapid diagnosis is key to the control and management of SARS-CoV-2. Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) testing usually requires a centralised laboratory and significant infrastructure. We describe the development and diagnostic accuracy assessment of a novel, rapid point-of-care RT-PCR test, the DnaNudge® platform CovidNudge test, which requires no laboratory handling or sample pre-processing.Methods Nasopharyngeal swabs are inserted directly into a cartridge which contains all reagents and components required for RT-PCR reactions, including multiple technical replicates of seven SARS-CoV-2 gene targets (rdrp1, rdrp2, e-gene, n-gene, n1, n2 and n3) and human ribonuclease P (RNaseP) as positive control. Between April and May 2020, swab samples were tested in parallel using the CovidNudge direct-to-cartridge platform and standard laboratory RT-PCR using swabs in viral transport medium. Samples were collected from three groups: self-referred healthcare workers with suspected COVID-19 (Group 1, n=280/386; 73%); patients attending the emergency department with suspected COVID-19 (Group 2, n=15/386; 4%) and hospital inpatient admissions with or without suspected COVID-19 (Group 3, n=91/386; 23%).Results Of 386 paired samples tested across all groups, 67 tested positive on the CovidNudge platform and 71 with standard laboratory RT-PCR. The sensitivity of the test varied by group (Group 1 93% [84-98%], Group 2 100% [48-100%] and Group 3 100% [29-100%], giving an average sensitivity of 94.4% (95% confidence interval 86-98%) and an overall specificity of 100% (95%CI 99-100%; Group 1 100% [98-100%]; Group 2 100% [69-100%] and Group 3 100% [96-100%]). Point of care testing performance was comparable during a period of high (25%) and low (3%) background prevalence. Amplification of the viral nucleocapsid (n1, n2, n3) targets were most sensitive for detection of SARS-CoV2, with the assay able to detect 1×104 viral particles in
AU - Gibani,M
AU - Toumazou,C
AU - Sohbati,M
AU - Sahoo,R
AU - Karvela,M
AU - Hon,T-K
AU - De,Mateo S
AU - Burdett,A
AU - Leung,F
AU - Barnett,J
AU - Orbeladze,A
AU - Luan,S
AU - Pournias,S
AU - Sun,J
AU - Flower,B
AU - Bedzo-Nutakor,J
AU - Amran,M
AU - Quinlan,R
AU - Skolimowska,K
AU - Klaber,R
AU - Davies,G
AU - Muir,D
AU - Randell,P
AU - Crook,D
AU - Taylor,G
AU - Barclay,W
AU - Mughal,N
AU - Moore,L
AU - Jeffery,K
AU - Cooke,G
DO - 10.1101/2020.08.13.20174193
PB - Cold Spring Harbor Laboratory
PY - 2020///
TI - CovidNudge: diagnostic accuracy of a novel lab-free point-of-care diagnostic for SARS-CoV-2
UR - http://dx.doi.org/10.1101/2020.08.13.20174193
UR - https://www.medrxiv.org/content/10.1101/2020.08.13.20174193v1
ER -